(61 days)
The Medline Single Patient Use Blood Pressure Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, infant, and adult sizes.
The Medline Single Patient Use Blood Pressure Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The device is non-sterile and disposable. It is available in neonatal, infant, and adult sizes.
This document is a 510(k) summary for the Medline Single Patient Use Blood Pressure Cuff. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain the detailed study information required to fill out the table regarding acceptance criteria and performance data. The document focuses on regulatory approval and indications for use, not a clinical study's methodology or results.
Therefore, I cannot provide the requested information from the given text.
The provided text does not contain information on:
- Acceptance criteria or device performance data.
- Sample sizes for test or training sets, nor data provenance.
- Number or qualifications of experts, nor adjudication methods.
- MRMC comparative effectiveness study details.
- Standalone algorithm performance.
- Type of ground truth used or how it was established.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).